Please fast-track approval for consumer smartwaches to monitor & track blood pressure.
As an American citizen and patient/consumer with hypertension, I am very conscientious of my blood pressure readings. I have a cuff that is connected with my Samsung Galaxy Health app to track my trends.
Many modern smart watches, like Apple Watch or Samsung Galaxy Watch, have advanced features to track body composition, sleep, ECG and heart rate. Manufacturerers have applied for FDA approval to monitor blood pressure - but have not received approval.
Wearing a watch that monitors my blood pressure, all day every day in real time, would give people like me a far more accurate picture of my overall hypertension trends.
Even if FDA mandates a disclaimer that the watch is not a medically-approved device, an abnormal reading would at least alert users to use an FDA-approved blood pressure cuff to verify it.
I look forward to hearing about FDA approval; and manufacturers being able to activate a health feature that, in many cases, is already in the watch but not yet available for use.
The sad part is they just approved Apple's watch. I use to have the Active 2 watch using a 3rd party BP app and comparing it to an approve cuff I found it very accurate so I am sure the newer watches like the watch 6 classic I have now is even better and yet still no approval. Sounds like a biased FDA to me. According to the FDA the watches have all the hardware it needs but they say it is software. Samsung should know what is lacking and probably has already fixed it but like all Android devices, Apple is praised to be the "GOD" of devices to everyone so they always put Apple first. I have Hypertension also and would like to track it throughout the day. We have these expensive tech devices capable if doing all these things but we can't use it because of an approval. Like you said, even if it is nit as accurate. Allow it to be used with a disclaimer that it is for reference and not approved to be accurate if that is the case.
Maybe they approved Apple's request because their device met the approval requirements and that Apple actually submitted it for approval. I do remember reading somewhere that Samsung has actually never submitted the device for FDA approval because they have no plans, currently, to implement it in the U.S. - perhaps they will change their position on that now that Apple has approval.
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